🧬FDA Classifies Mutation Detection Test for Myeloproliferative Neoplasms
The Food and Drug Administration (FDA, the Agency, or we) is classifying the mutation detection test for myeloproliferative neoplasms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the mutation detection test for myeloproliferative neoplasms. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Learn More💉Government-Owned EV-D68 Antibodies Now Available for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Learn More🧬Exclusive Patent License Opportunity for Biomedical Innovations
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to Cambridge Enterprise Limited, University of Cambridge, located in Cambridge, United Kingdom, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.
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